Fluid infusion device and related sealing assembly for a needleless fluid reservoir

ABSTRACT

Disclosed herein is a fluid infusion device of the type that delivers medication fluid to the body of a patient. The device includes or cooperates with a fluid reservoir, and the device has a sealing assembly to receive and form a fluid seal with the fluid reservoir. A retractable sealing element surrounding a hollow fluid delivery needle may be used to seal a port of the fluid reservoir. The port may include a pressure vent that is sealed by the retractable sealing element. In one variation, the reservoir includes a moving valve sleeve that holds a septum. The septum moves to allow the reservoir to vent, and to form a seal with the port when the needle pierces the septum. In another variation, the device includes a needleless sealing assembly. In yet other variations, the device uses a needled fluid reservoir.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/399,874, filed on Feb. 17, 2012. U.S. patent application Ser. No.13/399,874 claims the benefit of U.S. Provisional Patent ApplicationSer. No. 61/445,393, filed Feb. 22, 2011. The entire content of each ofthe above applications is incorporated by reference herein.

TECHNICAL FIELD

Embodiments of the subject matter described herein relate generally tofluid infusion devices for delivering a medication fluid to the body ofa user. More particularly, embodiments of the subject matter relate to asealing element that provides a fluid seal between a fluid deliveryneedle and a removable fluid reservoir.

BACKGROUND

Certain diseases or conditions may be treated, according to modernmedical techniques, by delivering a medication or other substance to thebody of a patient, either in a continuous manner or at particular timesor time intervals within an overall time period. For example, diabetesis commonly treated by delivering defined amounts of insulin to thepatient at appropriate times. Some common modes of providing insulintherapy to a patient include delivery of insulin through manuallyoperated syringes and insulin pens. Other modern systems employprogrammable fluid infusion devices (e.g., insulin pumps) to delivercontrolled amounts of insulin to a patient.

A fluid infusion device suitable for use as an insulin pump may berealized as an external device or an implantable device, which issurgically implanted into the body of the patient. External fluidinfusion devices include devices designed for use in a generallystationary location (for example, in a hospital or clinic), and devicesconfigured for ambulatory or portable use (to be carried by a patient).External fluid infusion devices may establish a fluid flow path from afluid reservoir to the patient via, for example, a suitable hollowtubing. The hollow tubing may be connected to a hollow fluid deliveryneedle that is designed to pierce the patient's skin to deliver aninfusion medium to the body. Alternatively, the hollow tubing may beconnected directly to the patient's body through a cannula or set ofmicro-needles.

The fluid reservoir of an external fluid infusion device may be realizedas a single-use prefilled disposable unit, a patient-filled unit, arefillable unit, or the like. The fluid reservoir for a typical fluidinfusion device is implemented as a removable and replaceable component.To this end, the fluid infusion device includes structure, features,and/or elements that are designed to establish the fluid flow path withthe fluid reservoir. For example, a fluid seal between the fluidreservoir and a hollow fluid delivery needle may be established when thefluid reservoir is properly installed in the fluid infusion device. Whenthe fluid reservoir is removed (for purposes of replacement, to allowcertain activities such as swimming or bathing, or the like), the fluiddelivery needle should be protected against contamination.

Accordingly, it is desirable to implement a sealing element that createsa seal between a removable fluid reservoir and a delivery needle of afluid infusion device. Furthermore, other desirable features andcharacteristics will become apparent from the subsequent detaileddescription and the appended claims, taken in conjunction with theaccompanying drawings and the foregoing technical field and background.

BRIEF SUMMARY

Various embodiments of a fluid infusion device, along with related fluidreservoirs and sealing elements for fluid reservoirs, are provided here.For example, an embodiment of a sealing element for a fluid infusiondevice is provided. The sealing element includes a base section, a tipsection extending from the base section, a retractable body sectionbetween the base section and the tip section, and a needle cavity formedin the retractable body section. The needle cavity continues through thebase section to define a needle opening in the base section, and theneedle cavity is sized to receive the hollow fluid delivery needle. Thesealing element also includes a self-sealing slit formed in the tipsection to accommodate the hollow fluid delivery needle when the sealingelement is in a retracted position.

Another embodiment of a sealing element for a fluid infusion device isalso provided. The sealing element includes a base section, a tipsection extending from the base section, a retractable body sectionbetween the base section and the tip section, and a needle cavity formedin the retractable body section and continuing through the base sectionto define a needle opening in the base section. The needle cavity issized to receive the hollow fluid delivery needle, and the needle cavitydefines internal relief features of the retractable body section. Theinternal relief features cause the sealing element to deform and retractover the hollow fluid delivery needle in response to a longitudinalforce applied to the tip section. In addition, the internal relieffeatures cause the sealing element to regain a nominal shape, extendover the hollow fluid delivery needle, and enclose the hollow fluiddelivery needle in response to removal of the longitudinal force.

An embodiment of a sealing assembly for a fluid infusion device is alsoprovided. The fluid infusion device cooperates with a fluid reservoirhaving a fluid delivery port. The sealing assembly includes a baseplate, a hollow fluid delivery needle coupled to the base plate toprovide a fluid flow path from the fluid reservoir to a user of thefluid infusion device, and a sealing element coupled to the base plateand overlying at least a portion of the hollow fluid delivery needle.The sealing element includes a base section, a tip section extendingfrom the base section, a retractable body section between the basesection and the tip section, a needle cavity formed in the retractablebody section and continuing through the base section to define a needleopening in the base section, and a self-sealing slit formed in the tipsection. The needle cavity is sized to receive the hollow fluid deliveryneedle, and the self-sealing slit accommodates the hollow fluid deliveryneedle when the sealing element is in a retracted position.

Another embodiment of a sealing assembly for a fluid infusion device isalso provided. The sealing assembly includes a base plate, a hollowfluid delivery needle coupled to the base plate to provide a fluid flowpath from the fluid reservoir to a user of the fluid infusion device,and a sealing element coupled to the base plate and overlying at least aportion of the hollow fluid delivery needle. The sealing elementincludes a base section, a tip section extending from the base section,a retractable body section between the base section and the tip section,and a needle cavity formed in the retractable body section andcontinuing through the base section to define a needle opening in thebase section. The needle cavity is sized to receive the hollow fluiddelivery needle, and the needle cavity defines internal relief featuresof the retractable body section. The internal relief features promotedeformation of the sealing element and retraction of the sealing elementover the hollow fluid delivery needle in response to a longitudinalforce applied to the tip section of the sealing element. Moreover, theinternal relief features cause the sealing element to automaticallyextend over the hollow fluid delivery needle into a nominal state inresponse to removal of the longitudinal force.

Also presented here is an embodiment of a fluid infusion device todeliver a fluid to a user. The fluid infusion device includes a baseplate, a hollow fluid delivery needle coupled to the base plate toprovide a fluid flow path from the fluid infusion device to the user,and a sealing element coupled to the base plate and overlying at least aportion of the hollow fluid delivery needle. The sealing elementincludes a base section, a tip section extending from the base section,a retractable body section between the base section and the tip section,a needle cavity formed in the retractable body section and continuingthrough the base section to define a needle opening in the base section,the needle cavity sized to receive the hollow fluid delivery needle, anda self-sealing slit formed in the tip section. The fluid infusion devicealso includes a removable fluid reservoir having a fluid delivery portto receive a tip of the hollow fluid delivery needle. When the removablefluid reservoir is removed from the hollow fluid delivery needle, theretractable body section extends such that the hollow fluid deliveryneedle is enclosed by the sealing element and such that the self-sealingslit forms a fluid seal to inhibit fluid ingress into the needle cavity.When the removable fluid reservoir is installed on the hollow fluiddelivery needle, the tip of the hollow fluid delivery needle extendsfrom the tip section and into the fluid reservoir, and the retractablebody section deforms to create a radial seal with an interior of thefluid delivery port.

Another embodiment of a fluid infusion device is also presented here.The fluid infusion device includes a base plate, a hollow fluid deliveryneedle coupled to the base plate to provide a fluid flow path from thefluid infusion device to the user, and a sealing element coupled to thebase plate and overlying at least a portion of the hollow fluid deliveryneedle. The sealing element includes a base section, a tip sectionextending from the base section, a retractable body section between thebase section and the tip section, and a needle cavity formed in theretractable body section and continuing through the base section todefine a needle opening in the base section. The needle cavity is sizedto receive the hollow fluid delivery needle, and the needle cavitydefines internal relief features of the retractable body section. Thefluid infusion device also includes a removable fluid reservoircomprising a fluid delivery port to receive a tip of the hollow fluiddelivery needle. The internal relief features promote deformation of thesealing element and retraction of the sealing element over the hollowfluid delivery needle when the removable fluid reservoir is engaged withthe sealing element and the hollow fluid delivery needle. The internalrelief features also cause the sealing element to automatically extendover the hollow fluid delivery needle, and cause the sealing element toassume a nominal state when the removable fluid reservoir is removedfrom the sealing element and the hollow fluid delivery needle.

Yet another embodiment of a fluid infusion device is also provided here.The fluid infusion device includes a base plate, a hollow fluid deliveryneedle coupled to the base plate to provide a fluid flow path for themedication fluid, and a sealing element coupled to the base plate andoverlying at least a portion of the hollow fluid delivery needle. Thesealing element includes a base section, a tip section extending fromthe base section, and a retractable body section between the basesection and the tip section. The fluid infusion device also includes afluid reservoir having a fluid chamber, a fluid delivery port coupled tothe fluid chamber, and at least one vent hole formed in the fluiddelivery port. The at least one vent hole provides a venting conduitfrom inside the fluid chamber to outside the fluid chamber. The fluiddelivery port engages and cooperates with the sealing element and thehollow fluid delivery needle such that the tip section of the sealingelement is urged against the fluid delivery port to seal the at leastone vent hole.

An alternative embodiment of a fluid reservoir is also presented here.The fluid reservoir includes a main body section that defines a fluidchamber for the medication fluid, a fluid delivery port coupled to andextending from the main body section, the fluid delivery port having afluid conduit and a pressure vent defined therein, and a septum locatedin the fluid delivery port and having a nominal non-pierced stateforming a fluid seal within the fluid conduit. The pressure ventprovides a venting conduit from inside the fluid chamber to outside thefluid chamber, and the pressure vent terminates at an exterior surfaceof the fluid delivery port. The exterior surface is contoured to matewith a resilient sealing element of the fluid infusion device to sealthe pressure vent.

Also disclosed here is an embodiment of a sealing assembly for a fluidinfusion device having a hollow fluid delivery needle, a retractablesealing element surrounding the hollow fluid delivery needle, and afluid reservoir. The sealing assembly includes a fluid delivery port forthe fluid reservoir, the fluid delivery port comprising a first sealingsurface, a pressure vent formed in the fluid delivery port to provide aventing conduit for a fluid chamber of the fluid reservoir, the pressurevent terminating at the first sealing surface, and a tip section for theretractable sealing element. The tip section has a second sealingsurface to mate with the first sealing surface, wherein the firstsealing surface and the second sealing surface are urged together toform a fluid seal for the pressure vent when the fluid reservoir isengaged with the hollow fluid delivery needle and the sealing element.

Another alternative embodiment of a fluid reservoir is presented here.The fluid reservoir includes a main body section that defines a fluidchamber for the medication fluid, and a fluid delivery port coupled toand extending from the main body section. The fluid delivery portincludes a fluid conduit that communicates with the fluid chamber, andthe fluid delivery port terminates at a port opening. The fluidreservoir also includes a septum movably coupled to the fluid deliveryport. The septum is movable between a sealed position where the septumforms a circumferential seal around the port opening, and a ventedposition that permits fluid to flow out of the fluid delivery port viathe port opening.

Yet another alternative embodiment of a fluid reservoir is presentedhere. The fluid reservoir includes a main body section that defines afluid chamber for the medication fluid, and a fluid delivery portcoupled to and extending from the main body section. The fluid deliveryport has a fluid conduit that communicates with the fluid chamber, andthe fluid delivery port terminates at a port opening. The fluidreservoir also includes a valve sleeve movably coupled to the fluiddelivery port, wherein the fluid delivery port and the valve sleevecooperate to accommodate translational movement of the valve sleeverelative to the fluid delivery port. A septum is located within thevalve sleeve and is movable in concert with the valve sleeve between asealed position and a vented position.

Also provided here is another alternative embodiment of a fluid infusiondevice that delivers a medication fluid to a body. The fluid infusiondevice includes a base plate, a hollow fluid delivery needle coupled tothe base plate to provide a fluid flow path for the medication fluid,and a fluid reservoir. The fluid reservoir includes a main body sectionthat defines a fluid chamber for the medication fluid, a fluid deliveryport coupled to and extending from the main body section, and a septumcoupled to the fluid delivery port. The fluid delivery port has a fluidconduit that communicates with the fluid chamber, and the fluid deliveryport terminates at a port opening. The septum translates relative to theport opening and is movable between a sealed position and a ventedposition. In the sealed position, the hollow fluid delivery needleengages the septum and urges the septum against the port opening to forma circumferential seal around the port opening. In the vented position,the hollow fluid delivery needle is disengaged from the septum.

Yet another embodiment of a fluid infusion device is also provided here.The fluid infusion device includes a fluid reservoir having a main bodysection that defines a fluid chamber for the medication fluid, and alsohaving a fluid delivery port coupled to and extending from the main bodysection. The fluid delivery port has a fluid conduit that communicateswith the fluid chamber, and the fluid delivery port terminates at anunsealed port opening. The fluid infusion device also includes aself-sealing reservoir port receptacle for the fluid delivery port. Theport receptacle has an inlet to receive the fluid delivery port, a valvechamber in fluid communication with the inlet, a valve element locatedin the valve chamber, and an outlet in fluid communication with thevalve chamber. The valve element is biased toward the inlet into asealed position to form a fluid seal between the valve element and theinlet, and the outlet provides a fluid flow path for the medicationfluid. Engagement of the fluid delivery port with the inlet causes anend of the fluid delivery port to move the valve element from the sealedposition to an opened position to accommodate flow of the medicationfluid into the valve chamber.

An alternative embodiment of a sealing assembly for a fluid infusiondevice is also presented here. The sealing assembly includes a reservoirport receptacle, an inlet formed in the reservoir port receptacle toreceive a fluid delivery port of a fluid reservoir that contains themedication fluid, and a valve chamber formed in the reservoir portreceptacle and in fluid communication with the inlet, a valve elementlocated in the valve chamber, a resilient compression element located inthe valve chamber to bias the valve element toward the inlet, and anoutlet formed in the reservoir port receptacle to provide a fluid flowpath for the medication fluid.

Another embodiment of a fluid infusion device is also presented here.The fluid infusion device includes a base plate, a delivery conduitcoupled to the base plate, wherein the delivery conduit provides themedication fluid to the body, and a self-sealing reservoir portreceptacle located on the base plate. The self-sealing reservoir portreceptacle includes an inlet to receive a fluid delivery port of a fluidreservoir, a valve chamber in fluid communication with the inlet, avalve element located in the valve chamber, and an outlet between thevalve chamber and the delivery conduit. When the fluid delivery port isdisengaged from the self-sealing reservoir port receptacle, the valveelement is biased toward the inlet into a sealed position to form afluid seal between the valve element and the inlet. The outlet providesa fluid flow path for the medication fluid. When the fluid delivery portis engaged with the self-sealing reservoir port receptacle, an end ofthe fluid delivery port moves the valve element from the sealed positionto an opened position to accommodate flow of the medication fluid fromthe fluid reservoir into the valve chamber.

Also presented here is an alternative embodiment of a fluid reservoirfor a fluid infusion device that delivers a medication fluid to a body.The fluid reservoir includes a main body section that defines a fluidchamber for the medication fluid, a hollow needle extending from themain body section and defining a fluid conduit that communicates withthe fluid chamber, the hollow needle terminating at a needle end, and aneedle hood extending from the main body section and at least partiallysurrounding the hollow needle. The needle hood terminates at a lip thatextends further from the main body section than the needle end.

Yet another alternative embodiment of a fluid infusion device is alsoprovided here. The fluid infusion device includes a base plate, adelivery conduit coupled to the base plate, wherein the delivery conduitprovides the medication fluid to the body, and a fluid reservoir. Thefluid reservoir has a main body section that defines a fluid chamber forthe medication fluid, a hollow needle extending from the main bodysection and in fluid communication with the fluid chamber, and a needlehood extending from the main body section and at least partiallysurrounding the hollow needle. The fluid infusion device also includes areservoir port receptacle located on the base plate and comprisingmating structure to engage and mate with the needle hood, a sealingelement to receive the hollow needle and form a seal around an exteriorsurface of the hollow needle, and an outlet conduit at least partiallydefined by the sealing element, wherein the outlet conduit is coupled tothe delivery conduit.

Also presented here is another embodiment of a fluid infusion devicethat delivers a medication fluid to a body. The fluid infusion deviceincludes a fluid reservoir having a main body section that defines afluid chamber for the medication fluid, and having a hollow needleextending from the main body section and in fluid communication with thefluid chamber. The fluid infusion device also includes a reservoir portreceptacle having a sealing element, and having mating structure toengage the fluid reservoir in an aligned orientation for introducing thehollow needle into the sealing element to form a seal around an exteriorsurface of the hollow needle.

Another embodiment of a fluid infusion device that delivers a medicationfluid to a body is provided. The fluid infusion device includes a fluidreservoir comprising a main body section that defines a fluid chamberfor the medication fluid, and comprising a fluid delivery port coupledto and extending from the main body section. The fluid delivery portcomprises a fluid conduit that communicates with the fluid chamber, andthe fluid delivery port terminates at an unsealed port opening. Thefluid infusion device includes a self-sealing reservoir port receptaclefor the fluid delivery port. The self-sealing reservoir port receptaclecomprises an inlet to receive the fluid delivery port, and a valvechamber in fluid communication with the inlet. A valve element islocated in the valve chamber, and the valve element biased toward theinlet to form a fluid seal between the valve element and the inlet. Theself-sealing reservoir port receptacle includes an outlet in fluidcommunication with the valve chamber to provide a fluid flow path forthe medication fluid. The fluid infusion device includes a sealingelement disposed in the inlet to form a seal with an outer surface ofthe fluid delivery port. The sealing element is positioned between theinlet and the valve chamber. Engagement of the fluid delivery port withthe inlet moves the valve element from a sealed position at the inletinto an opened position to accommodate flow of the medication fluid intothe valve chamber.

Also provided is a fluid infusion device that delivers a medicationfluid to a body. The fluid infusion device includes a fluid reservoircomprising a main body section that defines a fluid chamber for themedication fluid. The fluid reservoir comprises a fluid delivery portcoupled to and extending from the main body section. The fluid deliveryport comprises a fluid conduit that communicates with the fluid chamber,and the fluid delivery port terminates at an unsealed port opening. Theport opening includes a plurality of flow paths that allow themedication fluid to flow from the fluid conduit. The fluid infusiondevice includes a self-sealing reservoir port receptacle for the fluiddelivery port. The self-sealing reservoir port receptacle comprising aninlet to receive the fluid delivery port and a valve chamber in fluidcommunication with the inlet. A valve element is located in the valvechamber, and the valve element biased toward the inlet to form a fluidseal between the valve element and the inlet. The self-sealing reservoirport receptacle including an outlet in fluid communication with thevalve chamber to provide a fluid flow path for the medication fluid. Thefluid infusion device comprises a sealing element disposed in the inletto form a seal with an outer surface of the fluid delivery port.Engagement of the fluid delivery port with the inlet moves the valveelement from a sealed position at the inlet to an opened position toaccommodate flow of the medication fluid into the valve chamber, and themedication fluid flows from the fluid conduit through the plurality offlow paths and into the valve chamber.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the subject matter may be derived byreferring to the detailed description and claims when considered inconjunction with the following figures, wherein like reference numbersrefer to similar elements throughout the figures.

FIG. 1 is a perspective view of an embodiment of a fluid infusiondevice;

FIG. 2 is a perspective view that depicts internal structure of thedurable housing of the fluid infusion device shown in FIG. 1;

FIG. 3 is a perspective view that depicts internal structure of the baseplate of the fluid infusion device shown in FIG. 1;

FIG. 4 is a perspective view that depicts the reservoir port receptacleand a sealing element of the fluid infusion device shown in FIG. 1;

FIG. 5 is a cross-sectional and partially phantom view of a portion ofthe fluid infusion device, corresponding to a view along line 5-5 inFIG. 4;

FIG. 6 is an exploded perspective view of a sealing assembly suitablefor use with the fluid infusion device shown in FIG. 1;

FIG. 7 is a plan view of the sealing element shown in FIG. 6, as viewedfrom its base end;

FIG. 8 is a side elevation view of the sealing element shown in FIG. 6;

FIG. 9 is a front elevation view of the sealing element shown in FIG. 6;

FIG. 10 is a perspective view of the sealing element shown in FIG. 6;

FIG. 11 is a longitudinal cross-sectional view of the sealing elementshown in FIG. 6;

FIG. 12 is a cross-sectional and partially phantom view of a portion ofthe fluid infusion device, in a state where the fluid reservoir is fullyengaged with the sealing element;

FIG. 13 is a perspective view of an alternate embodiment of a sealingelement;

FIG. 14 is a phantom side view that depicts a portion of an alternativeembodiment of a sealing element;

FIG. 15 is a phantom perspective view that depicts a portion of analternative embodiment of a sealing element;

FIG. 16 is a phantom side view that depicts a portion of an alternativeembodiment of a sealing element;

FIG. 17 is a schematic side view of an embodiment of a vented fluidreservoir;

FIG. 18 is a top view of an embodiment of a vented fluid reservoir;

FIG. 19 is a phantom side view of an embodiment of a fluid reservoirthat includes a septum that serves as a pressure relief valve;

FIG. 20 is a phantom side view of the fluid reservoir shown in FIG. 19in a sealed state;

FIG. 21 is a longitudinal cross-sectional view of a fluid reservoir anda self-sealing reservoir port receptacle suitable for use with a fluidinfusion device;

FIG. 22 is an end view of the fluid reservoir as viewed from theperspective of line 22-22 in FIG. 21;

FIG. 23 is a perspective view of a first embodiment of a fluid reservoirthat includes a needle;

FIG. 24 is a cross-sectional view of a portion of the fluid reservoir,as viewed from the perspective of line 24-24 in FIG. 23;

FIG. 25 is a perspective view of a section of a fluid infusion device,including a reservoir port receptacle suitable for engagement with thefluid reservoir shown in FIG. 23;

FIG. 26 is a perspective view of a sealing and conduit componentsuitable for use with the fluid infusion device shown in FIG. 25;

FIG. 27 is a cross-sectional view of the section of the fluid infusiondevice, as viewed from the perspective of line 27-27 in FIG. 25;

FIG. 28 is a cross-sectional and partially phantom view that illustratesthe fluid reservoir (shown in FIG. 23) before engagement with thesection of the fluid infusion device (shown in FIG. 25);

FIG. 29 is a cross-sectional and partially phantom view that illustratesthe fluid reservoir (shown in FIG. 23) after engagement with the sectionof the fluid infusion device (shown in FIG. 25);

FIG. 30 is a cross-sectional view of a portion of a second embodiment ofa needled fluid reservoir;

FIG. 31 is a cross-sectional view of a section of a fluid infusiondevice that is designed to accommodate the needled fluid reservoir shownin FIG. 30;

FIG. 32 is a cross-sectional and partially phantom view that illustratesthe fluid reservoir (shown in FIG. 30) before engagement with thesection of the fluid infusion device (shown in FIG. 31);

FIG. 33 is a cross-sectional and partially phantom view that illustratesthe fluid reservoir (shown in FIG. 30) after engagement with the sectionof the fluid infusion device (shown in FIG. 31);

FIG. 34 is a perspective view of a third embodiment of a needled fluidreservoir;

FIG. 35 is a cross-sectional view of a portion of the fluid reservoir,as viewed from the perspective of line 35-35 in FIG. 34;

FIG. 36 is a perspective view of a section of a fluid infusion device,including a reservoir port receptacle suitable for engagement with thefluid reservoir shown in FIG. 34;

FIG. 37 is a cross-sectional view of the section of the fluid infusiondevice, as viewed from the perspective of line 37-37 in FIG. 36;

FIG. 38 is a cross-sectional and partially phantom view that illustratesthe fluid reservoir (shown in FIG. 34) before engagement with thesection of the fluid infusion device (shown in FIG. 36); and

FIG. 39 is a cross-sectional and partially phantom view that illustratesthe fluid reservoir (shown in FIG. 34) after engagement with the sectionof the fluid infusion device (shown in FIG. 36).

DETAILED DESCRIPTION

The following detailed description is merely illustrative in nature andis not intended to limit the embodiments of the subject matter or theapplication and uses of such embodiments. As used herein, the word“exemplary” means “serving as an example, instance, or illustration.”Any implementation described herein as exemplary is not necessarily tobe construed as preferred or advantageous over other implementations.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

Certain terminology may be used in the following description for thepurpose of reference only, and thus are not intended to be limiting. Forexample, terms such as “upper”, “lower”, “above”, and “below” could beused to refer to directions in the drawings to which reference is made.Terms such as “front”, “back”, “rear”, “side”, “outboard”, and “inboard”could be used to describe the orientation and/or location of portions ofthe component within a consistent but arbitrary frame of reference whichis made clear by reference to the text and the associated drawingsdescribing the component under discussion. Such terminology may includethe words specifically mentioned above, derivatives thereof, and wordsof similar import. Similarly, the terms “first”, “second”, and othersuch numerical terms referring to structures do not imply a sequence ororder unless clearly indicated by the context.

Various embodiments presented here are related to a sealing elementsuitable for use with a fluid reservoir and a fluid delivery needle ofthe type found in fluid infusion systems. In certain embodiments, thesealing element includes at least one slit formed in its tip toaccommodate a hollow needle. When a fluid reservoir is introduced andcoupled to the needle, the port of the fluid reservoir and/or anotherstructural feature of the reservoir urges the sealing element to retractover the needle such that the end of the needle penetrates the slit,protrudes from the tip of the sealing element, and enters the fluidreservoir. Upon fluid connection in this manner, the needle penetratesthe tip of the sealing element, which in turn outwardly expands thematerial (e.g., silicone) of the sealing element near the tip. Thereservoir port that receives the sealing element is sized and configuredsuch that expansion of the sealing element forms a radial seal betweenthe inner surface of the reservoir port and the sealing element. Furtherand complete installation of the reservoir onto the needle also createsa secondary backup face seal between the opening of the reservoir portand the sealing element.

Additional embodiments of various fluid reservoir configurations, needlesealing arrangements, and fluid interface designs are also presentedhere. For example, a number of vented fluid reservoir embodiments aredescribed below, where a pressure vent is incorporated into the fluidreservoir to facilitate the equalization of pressure that may otherwisebe present inside of the fluid reservoir and, therefore, to reduce thelikelihood of accidental fluid delivery caused by the build-up ofinternal pressure.

In addition, a “needleless” embodiment is presented here. In lieu of afluid delivery needle, a fluid reservoir is suitably configured tointeract with a sealing component or feature of a base plate of thefluid infusion device. The sealing component includes a valve member(e.g., a ball valve) that opens to accommodate fluid delivery from thefluid reservoir when the reservoir is introduced to the base plate. Whenthe reservoir is removed, the valve member automatically seals the flowpath.

Various embodiments of a fluid reservoir having a “hooded” or shieldedneedle or needle-like structure are also provided. The reservoir needleis designed to deliver the medication fluid to a corresponding fluidreceptacle of the fluid infusion device. The fluid receptacle includes asealing element that receives the reservoir needle and creates a fluidseal with the reservoir.

The following description relates to a fluid infusion device of the typeused to treat a medical condition of a patient. The infusion device isused for infusing fluid into the body of a user. The non-limitingexamples described below relate to a medical device used to treatdiabetes (more specifically, an insulin pump), although embodiments ofthe disclosed subject matter are not so limited. Accordingly, theinfused medication fluid is insulin in certain embodiments. Inalternative embodiments, however, many other fluids may be administeredthrough infusion such as, but not limited to, disease treatments, drugsto treat pulmonary hypertension, iron chelation drugs, pain medications,anti-cancer treatments, medications, vitamins, hormones, or the like.For the sake of brevity, conventional features and characteristicsrelated to infusion system operation, insulin pump and/or infusion setoperation, fluid reservoirs, and fluid syringes may not be described indetail here. Examples of infusion pumps and/or related pump drivesystems used to administer insulin and other medications may be of thetype described in, but not limited to: United States patent applicationnumber 2009/0299290 A1; United States patent application number2008/0269687; U.S. Pat. Nos. 7,828,764; and 7,905,868 (the entirecontent of these patent documents is incorporated by reference herein).

Retractable Needle Sealing Element

FIG. 1 is a perspective view of an exemplary embodiment of a fluidinfusion device 100. The fluid infusion device 100 includes two primarycomponents that are removably coupled to each other: a durable housing102; and a base plate 104. The fluid infusion device 100 also includesor cooperates with a removable/replaceable fluid reservoir 106. For theillustrated embodiment, the fluid reservoir 106 mates with, and isreceived by, the durable housing 102. In alternate embodiments, thefluid reservoir 106 mates with, and is received by, the base plate 104.FIG. 2 is a perspective view that depicts internal structure of thedurable housing 102, FIG. 3 is a perspective view that depicts internalstructure of the base plate 104, and FIG. 4 is a perspective view thatdepicts a reservoir port receptacle 108 and a sealing element 110 of thefluid infusion device 100.

The base plate 104 is designed to be temporarily adhered to the skin ofthe patient using, for example, an adhesive layer of material. After thebase plate is affixed to the skin of the patient, a suitably configuredinsertion device or apparatus may be used to insert a fluid deliveryneedle or cannula 112 (see FIG. 1) into the body of the patient. Thecannula 112 functions as one part of the fluid delivery path associatedwith the fluid infusion device 100, as is well understood.

FIG. 1 depicts the durable housing 102 and the base plate 104 coupledtogether. In practice, the durable housing 102 and/or the base plate 104may include features, structures, or elements to facilitate removablecoupling (e.g., pawls, latches, rails, slots, keyways, buttons, or thelike). As shown in FIG. 2, the durable housing 102 is designed toreceive the removable fluid reservoir 106 and to retain the fluidreservoir 106 in a particular position and orientation. Moreover, thedurable housing 102 is configured to secure to the base plate 104 in aspecified orientation to engage the fluid reservoir 106 with thereservoir port receptacle 108 (see FIG. 3). For this particularembodiment, the durable housing 102 contains, among other components, adrive motor, a battery, a threaded drive shaft for the fluid reservoir,one or more integrated circuit chips and/or other electronic devices(not shown). In particular embodiments, the fluid infusion device 100includes certain features to orient, align, and position the durablehousing 102 relative to the base plate 104 such that when the twocomponents are coupled together the fluid reservoir 106 is urged intothe reservoir port receptacle 108 to engage the sealing assembly andestablish a fluid seal, as described in more detail below.

The durable housing 102 and the base plate 104 are cooperativelyconfigured to accommodate removable coupling of the durable housing 102to the base plate 104. The removable nature of the durable housing 102enables the patient to replace the fluid reservoir 106 as needed.Moreover, the durable housing 102 can be removed (while leaving the baseplate 104 adhered to the patient) to allow the patient to swim, shower,bathe, and participate in other activities that might otherwise damageor contaminate the durable housing 102. When the durable housing 102 isremoved from the base plate 104, the fluid reservoir 106 is disengagedfrom the reservoir port receptacle 108, the fluid flow path is broken,and the base plate 104 will appear as shown in FIG. 4.

The fluid reservoir 106 includes a fluid delivery port 114 thatcooperates with the reservoir port receptacle 108. FIG. 3 depicts thefully installed position of the fluid reservoir 106 relative to the baseplate 104 and the reservoir port receptacle 108 (for ease ofillustration, the durable housing 102 is not shown in FIG. 3). The fluiddelivery port 114 may include a pierceable septum if the fluid reservoir106 is a prefilled unit. Alternatively, the fluid delivery port 114 mayinclude a vented opening to accommodate filling of the fluid reservoir106 by the patient, a doctor, a caregiver, or the like. The fluiddelivery port 114 has an interior 116 defined therein. As shown in FIG.5, the interior 116 is shaped, sized, and otherwise configured toreceive the sealing element 110 when the fluid reservoir 106 is engagedwith the reservoir port receptacle 108. In certain embodiments, theinterior 116 is conical, tapered, and/or funnel-shaped, as best shown inFIG. 5. This preferred shape of the interior 116 makes it easy for thesealing element 110 to mate with the fluid delivery port 114 when thedurable housing 102 is coupled to the base plate 104.

The sealing element 110 forms part of a sealing assembly 130 for thefluid infusion device 100. The sealing assembly 130 as referred to heremay also include the base plate 104 (or a portion thereof) and/or otherstructure or elements that cooperate with the sealing element 110. Theseadditional components will be described with reference to FIG. 5, whichis a cross-sectional and partially phantom view of a portion of thefluid infusion device 100 (corresponding to the view taken from line 5-5in FIG. 4) and with reference to FIG. 6, which is an explodedperspective view of the sealing assembly 130. The illustrated embodimentof the sealing assembly 130 generally includes, without limitation: thesealing element 110; a mounting cap 132; and a hollow fluid deliveryneedle 134. It should be appreciated that a portion of the base plate104 (e.g., the reservoir port receptacle 108 and/or the end portion ofthe base plate 104 that receives the sealing element 110 and themounting cap 132) may be considered to be part of the sealing assembly130.

The sealing assembly 130 may be formed by coupling the sealing element110 and the hollow fluid delivery needle 134 to the mounting cap 132. Inturn, the mounting cap 132 may be secured to the base plate 104 (seeFIG. 1 and FIG. 3). The sealing element 110 and the hollow fluiddelivery needle 134 may be secured to the mounting cap 132 using anadhesive, a bonding or welding agent, by a compression or snap fittingarrangement, or the like. The bottom surface 136 of the sealing element110 (see FIG. 6) forms a fluid seal with a mating surface of themounting cap 132. In certain embodiments, the mounting cap 132 includesa hollow protrusion 138 (which may be conical in shape) that extendsinto, and forms a fluid seal with, the base section of the sealingelement 110, as shown in FIG. 5. A portion of the hollow fluid deliveryneedle 134 extends through the hollow protrusion 138 and into thesealing element 110. As shown in FIG. 6, the hollow fluid deliveryneedle 134 for this particular embodiment is “J” shaped to provide afluid flow path from the sealing element 110, across the length of themounting cap 132, and into an outlet port 140 of the mounting cap 132.The outlet port 140 leads to a second sealing element 142 (which may beintegrally formed with the sealing element 110, as shown), which in turnleads into a fluid chamber 144 defined in the base plate 104. The fluidchamber 144 is fluidly coupled to the cannula 112 (FIG. 1) such thatwhen a plunger of the fluid reservoir 106 is actuated, the fluid isexpelled from the fluid reservoir 106, through the hollow fluid deliveryneedle 134, into the fluid chamber 144, and into the body of the patientvia the cannula 112.

FIGS. 7-10 show the sealing element 110 and the second sealing element142 in more detail, and FIG. 11 shows the sealing element 110 by itselfin cross-section. The sealing element 110 and the second sealing element142 may be integrally formed as a one-piece component from a resilientand deformable material, such as rubber, urethane, or the like. Incertain embodiments, the sealing element 110 and the second sealingelement 142 are formed from a pliable silicone material. The materialused for the sealing element and the second sealing element 142 isselected to be resistant to the fluid being delivered, biocompatible,and capable of being sterilized after manufacturing. The followingdescription focuses on the configuration, characteristics, andfunctionality of the sealing element 110 (the figures include the secondsealing element 142 for the sake of completeness and for consistencywith the exemplary embodiment).

The sealing element 110 includes a base section 150, a tip section 152extending from the base section 150, and a retractable body section 154between the base section 150 and the tip section 152. In practice, thesealing element 110 is a one-piece component and, accordingly, the basesection 150, the tip section 152, and the retractable body section 154are integrally formed and continuous with one another. Referring to FIG.11, the sealing element 110 includes a needle cavity 155 formed therein.More specifically, the needle cavity 155 is formed within theretractable body section 154, and it continues through the base section150 to define a needle opening 156 in the base section 150. Theexemplary embodiment depicted in the figures includes a tapered orconical shaped needle opening 156 that mates with the outer contour ofthe hollow protrusion 138 (see FIG. 5), which in turn accommodates thehollow fluid delivery needle 134. As shown in FIG. 5, the needle cavity155 is shaped, sized, and configured to receive the hollow fluiddelivery needle 134.

The base section 150 generally corresponds to the portion of the sealingelement 110 that is coupled to the base plate 104 (by way of themounting cap 132). Notably, the mounting cap 132 and the hollow fluiddelivery needle 134 are coupled to the base plate 104 in a substantiallyfixed and rigid manner such that the hollow fluid delivery needle 134protrudes from the mounting cap 132 and extends within the reservoirport receptacle 108 (see FIG. 4). The sealing element 110, however, is apliable and deformable feature. FIG. 4 depicts the sealing element 110in its natural nominal state without the fluid reservoir 106 in place.In this nominal state, the tip section 152 of the sealing element 110extends slightly beyond the lip of the reservoir port receptacle 108.The sealing element 110 is configured to retract over the hollow fluiddelivery needle 134 when the fluid reservoir 106 engages the base plate104 (in FIG. 3 the fluid reservoir 106 is fully engaged with thereservoir port receptacle 108).

The tip section 152 may be mushroom or barb shaped in variousembodiments, as shown in FIGS. 8-11. The barbed shape of the tip section152 promotes entry and seating of the sealing element 110 into the fluiddelivery port 114 of the fluid reservoir 106. Moreover, the barbed shapeconfiguration helps to establish a good radial seal between the sealingelement 110 and the interior 116 of the fluid delivery port 114(described in more detail below).

Referring to FIG. 5 and FIG. 11, the sealing element 110 may alsoinclude at least one self-sealing slit 160, slot, opening, or holeformed in the tip section 152 to accommodate the hollow fluid deliveryneedle 134 when the sealing element is in a retracted position. Theself-sealing slit 160 may be realized as a very fine slice or punctureformed in the tip section 152 for purposes of guiding the end of thehollow fluid delivery needle 134 through the material of the sealingelement 110 as needed. The self-sealing slit 160 is preferred over anembodiment that relies on repeated punctures of the tip section 152 witha sharp or pointed needle. For this particular embodiment, a flat orblunt ended hollow fluid delivery needle 134 can be utilized because theself-sealing slit 160 provides a pre-existing pathway through the tipsection 152.

The self-sealing slit 160 expands to accommodate passage of the hollowfluid delivery needle 134, and it automatically returns to a “closed”and sealed state when the fluid reservoir 106 is removed from the baseplate 104. The sealed state is depicted in FIG. 5—the hollow fluiddelivery needle 134 is fully enclosed within the sealing element 110 andthe end of the hollow fluid delivery needle 134 is positioned behind theself-sealing slit 160. More specifically, the sealing element 110 isoverlying the protruding portion of the hollow fluid delivery needle134, which is located within the retractable body section 154. In thisstate, the self-sealing slit 160 closes to inhibit fluid ingress intothe needle cavity 155 and to protect the hollow fluid delivery needle134 from contamination.

The illustrated embodiment of the sealing element 110 also includes anintegral guide channel 162 formed in the tip section 152. The guidechannel 162 is in communication with the needle cavity 155 and theself-sealing slit 160, as best shown in FIG. 11. The guide channel 162may be realized as an opening or neck region having a smaller dimension(e.g., diameter) than the end of the needle cavity 155, but a largerdimension than the self-sealing slit 160. This arrangement andconfiguration enables the guide channel 162 to guide/lead the tip of thehollow fluid delivery needle 134 into the self-sealing slit 160 duringretraction of the sealing element 110 over the hollow fluid deliveryneedle 134. In practice, the guide channel 162 increases the likelihoodof the hollow fluid delivery needle 134 entering the self-sealing slit160 rather than “catching” and puncturing the material forming the tipsection 152.

Referring to FIG. 11, the needle cavity 155 is suitably configured suchthat it defines internal relief features 164 and/or an internal reliefstructure of the retractable body section 154. In operation, theinternal relief features 164 facilitate retraction of the sealingelement 110 over the hollow fluid delivery needle 134 in response to alongitudinal force applied to the tip section 152. Longitudinal force ofthis type may be imparted to the tip section 152 when the durablehousing 102 is coupled to the base plate 104 and, consequently, when thefluid delivery port 114 of the fluid reservoir 106 engages the reservoirport receptacle 108 of the base plate 104 (see FIG. 3). The internalrelief features 164 also cause the sealing element 110 to beself-biasing or spring-like such that the sealing element 110 extendsover and covers the hollow fluid delivery needle 134 in response to theremoval of the longitudinal force. This extended position is depicted inFIGS. 5-11.

The internal relief features 164 allow the sealing element 110 tocompress and deform easily when the fluid reservoir 106 is introduced.Moreover, the internal relief features 164 function as a spring whenunder compression. In this regard, the internal relief features 164 urgethe tip section 152 outward and beyond the end of the hollow fluiddelivery needle 134 when the fluid reservoir 106 is withdrawn. Thespecific configuration of the internal relief features 164 may vary fromone embodiment to another, and the exemplary arrangement depicted inFIG. 11 is not intended to be exhaustive or otherwise limiting. As shownin FIG. 11, the internal relief features 164 may include or be arrangedas an accordion structure within the needle cavity 155. Alternatively(or additionally), the internal relief features 164 may include one or aplurality of internal annular channels formed within the needle cavity155. Alternatively (or additionally), the internal relief features 164may include one or a plurality of internal annular ridges or ribs withinthe needle cavity 155. Alternatively (or additionally), the internalrelief features 164 may include one or a plurality of bottleneckstructures resident within the needle cavity 155. The embodiment shownin FIG. 11 includes a number of annular channels alternating with aplurality of annular ridges. This arrangement of channels and ridgesresults in a plurality of bottleneck regions, which in turn form thespring-like accordion structure.

The mechanical characteristics, sealing characteristics, and functionalaspects of the sealing element 110 will now be described with primaryreference to FIGS. 4, 5, 11, and 12. The fluid infusion device 100 and,more specifically, the sealing element 110 may be manipulated intovarious states associated with the coupling status of the fluidreservoir 106 relative to the sealing assembly 130 (FIG. 6), the sealingelement 110, the reservoir port receptacle 108, etc. The differentstates may also be specified with respect to the coupling status of thedurable housing 102 relative to the base plate 104. In this regard, onestate may be defined as the “separated” or “disconnected” or“disengaged” state where the durable housing 102 and the base plate 104are separated from each other (or are otherwise decoupled) such that thefluid delivery port 114 is fully disengaged from the sealing element110. FIG. 4 depicts the base plate 104 in its disconnected state.Another state may be defined as the “connected” or “engaged” state wherethe durable housing 102 and the base plate 104 are fully coupledtogether, as depicted in FIG. 1. This description assumes that the fluidreservoir 106 is properly located and installed within the durablehousing 102 (see FIG. 2). Consequently, when the fluid infusion device100 is in the connected state, the fluid delivery port 114 is receivedwithin the reservoir port receptacle 108, and the interior 116 of thefluid delivery port 114 engages the sealing element 110. FIG. 12 is alongitudinal cross-sectional view that schematically depicts theconnected state of the fluid infusion device 100. In contrast, FIG. 5shows the fluid infusion device 100 in an intermediate state where thedurable housing 102 and the base plate 104 have been introduced to oneanother and oriented for coupling together. In this intermediate state,the fluid delivery port 114 has partially engaged the reservoir portreceptacle 108, but the sealing element 110 has not yet been retractedover the hollow fluid delivery needle 134.

The sealing element 110 has a nominal state, which is depicted in FIGS.4-11, and a retracted state, which is depicted in FIG. 12. The sealingelement 110 naturally assumes its nominal state when the fluid infusiondevice 100 is in the disconnected state, and when the fluid infusiondevice 100 is in the intermediate state described above. When in thenominal state, the tip of the hollow fluid delivery needle 134 resideswithin the needle cavity 155 (see FIG. 5). In other words, the sealingelement 110 encloses the hollow fluid delivery needle 134 when thesealing element 110 is in the nominal state. Consequently, theself-sealing slit 160 is free to return to its natural position to forma fluid seal for the needle cavity 155. Thus, when the sealing element110 is in the nominal state, the self-sealing slit 160 inhibits fluidingress into the needle cavity, which is desirable to prevent orminimize contamination of the hollow fluid delivery needle 134.

In contrast, the sealing element 110 is urged into its retracted statewhen the fluid infusion device 100 is in the connected state. Thetransition from the intermediate state to the connected state isassociated with the application of longitudinal force (imparted by thefluid delivery port 114) to the tip section 152 of the sealing element110. The longitudinal force is imparted to the tip section 152 when thedurable housing 102 is coupled to the base plate 104—the action ofcoupling the durable housing 102 to the base plate 104 causes the fluiddelivery port 114 to move toward the mounting cap 132, which in turnreduces the distance between the interior 116 of the fluid delivery port114 and the mounting cap 132. In response to this reduction in distance,the sealing element 110 is deformed and crushed such that it retractsover the hollow fluid delivery needle 134. Notably, the internal relieffeatures 164 promote the deformation and retraction of the sealingelement 110 over the hollow fluid delivery needle 134 in response toforce applied to the tip section 152, which is caused by forwardmovement of the fluid reservoir 106. Retraction of the sealing element110 causes the tip 172 of the hollow fluid delivery needle 134 to be ledthrough the guide channel 162 and into the self-sealing slit 160, suchthat the tip 172 protrudes from the tip section 152 (see FIG. 12) andsuch that an end section 173 of the hollow fluid delivery needle 134resides in the self-sealing slit 160. Thus, when the removable fluidreservoir 106 is installed on the hollow fluid delivery needle 134, thetip 172 extends from the tip section 152 of the sealing element 110 andinto the fluid reservoir 106.

The sealing element 110 interacts with the fluid delivery port 114 toestablish a fluid seal. Referring to FIG. 11 and FIG. 12, theretractable body section 154 of the sealing element 110 has an exteriorsurface 174. When the sealing element 110 is in its nominal state (FIGS.4-11), the exterior surface 174 is “relaxed” and it resembles a smoothcylindrical surface. Due to the deformable characteristics of thesealing element 110, however, the exterior surface 174 moves outwardwhen the sealing element 110 is retracting over the hollow fluiddelivery needle 134, especially when the hollow fluid delivery needle134 protrudes from the tip section 152 and displaces the seal material.This outward movement of the exterior surface 174 corresponds to anoutward expansion of the retractable body section 154. The retractablebody section 154 continues to expand in this manner until it abuts theinterior 116 of the fluid delivery port 114, as depicted in FIG. 12.Thus, as the tip section 152 engages the fluid delivery port 114, thesealing element 110 creates an initial seal with the fluid delivery port114. In addition, the retractable body section 154 expands to form aradial seal with the interior 116 when the fluid reservoir 106 engagesthe sealing element 110 and the hollow fluid delivery needle 134. Thetip section 152 of the sealing element 110 also abuts the interior 116of the fluid delivery port 114, which enhances the fluid seal.

The internal relief features 164 facilitate compression of the sealingelement 110 into the retracted state shown in FIG. 12. The internalrelief features 164 also provide resiliency to enable the sealingelement 110 to regain its nominal shape when the durable housing 102 isremoved and, consequently, the fluid delivery port 114 is disengagedfrom the sealing element 110 and the hollow fluid delivery needle 134.In other words, the sealing element 110 automatically and naturallysprings back into its nominal position, and extends over and covers thehollow fluid delivery needle 134, when the fluid infusion device 100transitions from the connected state to the disconnected state. For thisreason, the internal relief features 164 are preferably designed,arranged, and configured to provide spring-like characteristics to thesealing element 110.

FIGS. 13-16 depict sealing elements configured in accordance with threealternate embodiments. Any of these alternative embodiments could beutilized in lieu of the sealing element 110 described above. Thesealternate embodiments share many features, characteristics, andfunctions with the sealing element 110. For the sake of brevity, commonaspects of these sealing elements will not be described in detail here.

FIG. 13 is a perspective view of an alternate embodiment of a sealingelement 200, which may be suitable for use in lieu of the sealingelement 110. The sealing element 200 shares many features andcharacteristics with the sealing element 110 and, indeed, the internalstructures of the sealing elements 110, 200 may be similar or identical.For example, the sealing element 200 also includes a self-sealing slit201 to accommodate a needle. The sealing element 200 employs a graduallytapered retractable body section 202 that transitions smoothly andcontinuously with a tip section 204. In contrast, the sealing element110 employs a barbed tip section 152.

FIG. 14 is a phantom side view that depicts a portion of an alternateembodiment of a sealing element 300. The sealing element 300 includes arelatively straight and smooth cylindrical retractable body section 302that transitions to a tip section 304. In contrast to the embodimentsdescribed previously, the sealing element 300 also includes acircumferential compression element 306 coupled around the tip section304. The circumferential compression element 306 is suitably designed,shaped, and sized to impart an inward biasing force to a self-sealingslit 308 formed in the tip section 304. Consequently, when the sealingelement 300 is in its natural and nominal state (as depicted in FIG.14), the circumferential compression element 306 urges the self-sealingslit 308 closed to enhance the seal for the needle cavity 310.

In certain embodiments, the circumferential compression element 306 isrealized as a physically distinct and separate component that isattached to the material that forms the bulk of the sealing element 300.For example, the circumferential compression element 306 could beaffixed to the tip section 304 using an adhesive, a bonding agent, orthe like. Alternatively, the circumferential compression element 306could be coupled to the tip section 304 by way of a compression fitand/or by way of structural features that secure the circumferentialcompression element 306 to the tip section 304 (e.g., keyway features,tabs, ridges, or the like). In accordance with one exemplary embodiment,the circumferential compression element 306 is realized as a resilientband that resists deformation more than the material that forms the tipsection 304.

FIG. 15 is a phantom perspective view that depicts a portion of anotheralternate embodiment of a sealing element 400. The sealing element 400is similar to the sealing element 300 in that it also includes acircumferential compression element 406. For this embodiment, however,the circumferential compression element 406 is realized as a rigid ringthat encircles most if not all of the tip section 404. In accordancewith one exemplary embodiment, the circumferential compression element406 is realized as a metal compression ring that can be installed overthe tip section 404 by bending or deforming it to achieve the desiredamount of compression.

FIG. 16 is a phantom side view that depicts a portion of yet anotheralternate embodiment of a sealing element 500. The sealing element 500includes a tip section 504 having a different shape and profile(relative to the embodiments described previously). The shape of the tipsection 504 is similar to the shape of the tip section 152 in that it iswider than the retractable body section 502. This wide tip section 504is desirable to establish a good fluid seal with the fluid reservoir.Moreover, the additional material that is used to form the wide tipsection 504 serves to enhance the integrity of the self-sealing slit508.

It should be appreciated that the specific features and characteristicsshown and described above for the various exemplary embodiments areneither exclusive nor required for any given embodiment. For example,any of the exemplary sealing elements described above could be providedwith or without a circumferential compression element for the tipsection. As another example, the specific shape and configuration of thetip section may vary from one embodiment to another. Thus, theindividual features and elements shown and described may be implementedand deployed in an embodiment of a fluid infusion device as desired tosuit the needs of the particular application.

Vented Fluid Reservoirs

An open or vented fluid reservoir may be utilized to reduce or eliminateexcess pressure that might otherwise be introduced into the fluidchamber of the reservoir during a filling operation. In this regard, avented fluid reservoir allows the pressure to equalize before thereservoir is coupled to the fluid infusion device and, therefore,reduces or eliminates the likelihood of unintended fluid delivery. Tothis end, one embodiment described here includes a vented port or funnelto relieve the pressure in the reservoir. Another embodiment describedbelow employs a movable septum that functions as a pressure relief valvefor the fluid reservoir.

FIG. 17 depicts a schematic side view representation of a vented fluidreservoir 600, and FIG. 18 is a top view of an exemplary embodiment ofthe vented fluid reservoir 600. For ease of understanding andillustration, FIG. 17 depicts some structure in cross section and somestructure in phantom. The fluid reservoir 600 may be utilized with thefluid infusion device 100 (or a slightly modified version thereof)described above with reference to FIGS. 1-6. Accordingly, commonfeatures, structures, elements, and functionality will not beredundantly described here in the context of the fluid reservoir 600.

Referring to FIG. 17, the fluid reservoir 600 may cooperate with a fluidinfusion device (not shown) having a hollow fluid delivery needle 602and a sealing element 604 overlying at least a portion of the hollowfluid delivery needle 602. The sealing element 604 may exhibit any ofthe features, structures, or elements described above, as appropriatefor the particular embodiment. As described above for the previousembodiments, the sealing element 604 may terminate at a tip section 606through which a tip 608 of the hollow fluid delivery needle penetrateswhen the fluid reservoir 600 is engaged with the hollow fluid deliveryneedle 602 and with the sealing element 604 (see, for example, FIG. 12).For this particular embodiment, the tip section 606 is barbed ormushroom shaped such that it has a tapered convex exterior surface 610.

The fluid reservoir 600 generally includes, without limitation: a mainbody section 620; a filling port 621; a fluid delivery port 622; afunnel element 623; and a septum 624. The main body section defines afluid chamber 626 for the medication fluid that is to be delivered bythe fluid infusion device. The filling port 621 is in fluidcommunication with the fluid chamber 626 to accommodate filling of thefluid chamber 626 with the desired medication fluid (using a syringe orfill needle, as is well understood). The fluid delivery port 622 iscoupled to, and extends from, the main body section 620. The fluiddelivery port 622 is in fluid communication with the fluid chamber 626to provide a fluid flow path from inside the fluid chamber 626 to thehollow fluid delivery needle 602 (this fluid flow path is establishedand maintained when the fluid reservoir 600 is engaged with the baseplate of the fluid infusion device).

The funnel element 623 is coupled within the fluid delivery port 622. Incertain embodiments, the main body section 620 and the fluid deliveryport 622 are formed from a first material (such as plastic) and thefunnel element 623 is formed from a second material (such as metal). Thefunnel element 623 may be implemented as an insert that can be seatedwithin and coupled to the fluid delivery port 622 in any suitable mannersuch that the funnel element 623 remains in a fixed position. Notably,the funnel element 623 includes a tapered, conical, or convex interiorsurface 628. This interior surface 628 represents one surface of thereceptacle that is defined by the funnel element 623. As schematicallyillustrated in FIG. 17, the funnel element 623 is shaped, sized, andconfigured in accordance with the sealing element 604. This enables theinterior surface 628 of the funnel element 623 and the exterior surface610 of the sealing element 604 to mate with one another and cooperate toform a fluid tight seal when they are forced together.

The septum 624 is located and held in place in the funnel element 623.The septum 624 may be formed from a soft, resilient, and pliablematerial that has certain self-sealing or self-restoring properties. Forexample, the septum 624 may be formed from a silicone rubber material incertain embodiments. Depending upon the embodiment, the septum 624 maybe provided in a solid and continuous form, or it may be provided with aslit, a cut, or an equivalent feature that makes it easier to piercewhile still maintaining at least a nominal seal. The septum 624 has anominal non-pierced state (depicted in FIG. 17) where the needle doesnot protrude through the septum 624. In the non-pierced state, theseptum 624 forms a fluid seal within a fluid conduit 630 defined by thefluid reservoir 600. Thus, the medication fluid inside the fluid chamber626 cannot flow within the fluid conduit 630 when the fluid reservoir600 is in the disengaged state shown in FIG. 17. However, when the fluidreservoir 600 is properly engaged with the hollow fluid delivery needle602 and with the sealing element 604, the tip 608 of the hollow fluiddelivery needle 602 penetrates the septum 624 to create a fluid flowpath from the fluid chamber 626 through the septum 624. Accordingly, thehollow fluid delivery needle 602 pierces the septum 624 to facilitatedelivery of the medication fluid from the fluid chamber to the hollowfluid delivery needle 602.

In various embodiments, the fluid delivery port 622 and/or the funnelelement 623 include a pressure vent formed therein. The pressure ventmay take any suitable form or arrangement. For example, the pressurevent may be realized with one or more vent holes. As another example,the pressure vent may be realized with one or more slits or any otheropening formed within the funnel element 623. The exemplary embodimentsshown in FIG. 17 and FIG. 18 employ small diameter vent holes 640 formedin the funnel element 623. As shown in FIG. 18, the vent holes 640 maybe arranged around the perimeter of the fluid delivery port and/oraround the perimeter of the funnel element 623. As depicted in FIG. 17,the vent holes 640 may be located around the outer perimeter of theseptum 624. Thus, the vent holes 640 create venting conduits that passaround the septum 624 and pass around the fluid conduit 630. Inpractice, the vent holes 640 are sized to minimize leakage of themedication fluid caused by gravity or handling of the fluid reservoir600. Of course, if the fluid chamber 626 is highly pressurized, thensome medication fluid may be forced out of the vent holes 640 while thefluid chamber 626 equalizes.

Each vent hole 640 provides a venting conduit from inside the fluidchamber 626 to outside the fluid chamber 626. More specifically, eachvent hole 640 is realized as a fluid conduit that communicates at oneend with the fluid chamber 626 and at the other end with the interiorsurface 628 of the funnel element 623. Thus, each vent hole 640terminates at the interior surface 628. When the fluid reservoir 600 isdisengaged from the fluid infusion device, the vent holes 640 may bevisible from the top of the fluid reservoir 600, as shown in FIG. 18.

In operation, the fluid delivery port 622 and the funnel element 623engage and cooperate with the sealing element 604 and with the hollowfluid delivery needle 602 in the manner generally described above withreference to the fluid infusion device 100. When the fluid delivery port622 is installed and pressed over the sealing element 604, the tipsection 606 of the sealing element 604 is urged against the contouredinterior surface 628 of the funnel element 623. This action causes theexterior surface 610 of the sealing element 604 to contact and mate withthe interior surface 628 of the funnel element 623. In turn, the tipsection 606 (which may deform or expand in response to the coupling)covers and seals the vent holes 640. As mentioned previously, the tip608 of the hollow fluid delivery needle pierces the septum 624 when thefluid reservoir 600 is introduced. In certain embodiments, the fluiddelivery port 622, the funnel element 623, the sealing element 604, andthe hollow fluid delivery needle 602 are cooperatively configured suchthat the tip section 606 of the sealing element 604 seals the vent holes640 before the hollow fluid delivery needle 602 pierces the septum 624.This reduces or eliminates leakage of the medication fluid. The ventholes 640 remain sealed in this manner during operation of the fluidinfusion device, such that the medication fluid is forced from the fluidchamber 626 and through the hollow fluid delivery needle 602 in theintended manner.

Another embodiment of a vented fluid reservoir will now be describedwith reference to FIG. 19 and FIG. 20. FIG. 19 is a phantom side view ofa fluid reservoir 700 in an open or vented state, and FIG. 20 is aphantom side view of the fluid reservoir 700 in a sealed state. Itshould be appreciated that the fluid reservoir 700 may be utilized withthe fluid infusion device 100 (or a slightly modified version thereof)described above with reference to FIGS. 1-6. Accordingly, commonfeatures, structures, elements, and functionality will not beredundantly described here in the context of the fluid reservoir 700.

The illustrated embodiment of the fluid reservoir 700 generallyincludes, without limitation: a main body section 702; a fluid deliveryport 704; a valve sleeve 706; and a septum 708. The main body section702 includes a fluid chamber 710 defined therein. The fluid chamber 710accommodates the medication fluid to be delivered to the patient. Thefluid delivery port 704 is coupled to and extends from the main bodysection 702. In certain embodiments, the fluid delivery port 704 isintegrally formed with the main body section 702. For example, the fluiddelivery port 704 and the main body section 702 may be fabricated from amolded plastic material. The fluid delivery port 704 includes or definesa fluid conduit 712 that communicates with the fluid chamber 710.

This particular embodiment of the fluid delivery port 704 has agenerally cylindrical shape that resembles a neck region extending fromthe main body section 702. The fluid delivery port 704 terminates at aport opening 714. The port opening 714 is realized as a round rim or lipat the end of the fluid delivery port 704. As shown in FIG. 19 and FIG.20, the perimeter edge of the fluid delivery port 704 may be beveled or“pointed” if so desired (beveling in this manner may be desirable forpurposes of creating a good seal with the septum 708).

Although not always required, the illustrated embodiment of the fluiddelivery port 704 includes a circumferential groove 716 formed therein(around the outer surface). The groove 716 may be defined as a regionbetween a shoulder 718 of the main body section 702 and a barb portion720 of the fluid delivery port 704. For this embodiment, the barbportion 720 is located at or near the port opening 714. In alternativeembodiments, the groove 716 could be positioned anywhere along thelength of the fluid delivery port 704. The groove 716 receives aninterior ridge 724 of the valve sleeve 706, which is formed within anattachment receptacle of the valve sleeve 706. This attachmentreceptacle is generally defined by the interior region below the septum708 in FIG. 19 and FIG. 20. The attachment receptacle is shaped, sized,and otherwise configured to receive the fluid delivery port 704 as shownin the figures. The interior ridge 724 may be implemented as acontinuous protrusion positioned within the attachment receptacle suchthat it completely encircles the fluid delivery port 704. The dimensionsof the interior ridge 724 and the groove 716 are selected such that thevalve sleeve 706 can be “snapped” into place and retained on the fluiddelivery port 704 in a manner that accommodates translational movementof the valve sleeve 706 relative to the fluid delivery port 704.

Notably, the groove 716 allows the valve sleeve 706 to move toward thefluid chamber 710 until movement is inhibited by the shoulder 718 and/orby other structure of the fluid reservoir 700, or until movement isinhibited by engagement between the septum 708 and the port opening 714(see FIG. 20). Similarly, the groove 716 allows the valve sleeve 706 tomove away from the fluid chamber 710 until movement of the interiorridge 724 is inhibited by the barb portion 720 of the fluid deliveryport 704 (see FIG. 19). Thus, the valve sleeve 706 is movably coupled tothe fluid delivery port 704, and the attachment receptacle of the valvesleeve 706 is sized to accommodate translation of the valve sleeve 706relative to the fluid delivery port 704 and, more particularly, relativeto the port opening 714.

The septum 708 is located within a septum receptacle 728 defined withinthe valve sleeve 706. The septum receptacle 728 may be realized as aninterior groove or channel formed in the inner wall of the valve sleeve706. In the illustrated embodiment, the septum receptacle 728 isadjacent to the attachment receptacle, such that one surface of theseptum 708 (i.e., the lower surface in FIG. 19 and FIG. 20) defines aboundary of the attachment receptacle. The septum receptacle 728receives and holds the septum 708 in a fixed position relative to thevalve sleeve 706. In other words, the septum receptacle 728 maintainsthe septum 708 in place such that the septum 708 translates in concertwith the valve sleeve 706. In this regard, the septum 708 is movablycoupled to the fluid delivery port 704 by way of the valve sleeve 706.

The valve sleeve 706 also includes a sleeve opening 730 that is adjacentto the septum receptacle 728. The sleeve opening 730 is arranged suchthat at least a portion of the septum 708 is accessible via the sleeveopening 730. As shown in FIG. 19 and FIG. 20, the upper surface of theseptum 708 is exposed in the sleeve opening 730. The sleeve opening 730allows a hollow fluid delivery needle of the fluid infusion device topierce or otherwise pass through the septum 708 to gain entry to thefluid conduit 712.

The valve sleeve 706 and the septum 708 are movable between a sealedposition (shown in FIG. 20) and an open or vented position (shown inFIG. 19). The sealed position is achieved when the fluid reservoir 700is engaged with the fluid delivery needle of the fluid infusion device.More specifically, the septum 708 and the valve sleeve 706 are urgedinto the sealed position when the fluid delivery needle is forcedagainst and through the septum 708. Additionally or alternatively, theseptum 708 could be urged into the sealed position when the valve sleeve706 abuts structure of the base plate. When in the sealed position, thesurface of the septum 708 contacts the port opening 714 to form acircumferential seal around the port opening 714. This seal inhibitsfluid flow between the fluid delivery port 704 and the septum 708 duringa delivery cycle (which is intended to force the medication fluidthrough the delivery needle). For simplicity, the needle and itsassociated base plate mounting structure are not shown in FIG. 20.

When the fluid reservoir 700 is removed from the fluid infusion deviceand, therefore, is disengaged from the fluid delivery needle, the valvesleeve 706 and the septum 708 are free to move relative to the fluiddelivery port 704. Accordingly, the valve sleeve 706 and the septum 708are free to move into the vented position in response to a pressuredifferential condition where pressure in the fluid chamber 710 exceedsthe ambient pressure. Under these conditions, the excess pressure insidethe fluid chamber 710 can be released through the port opening 714because the valve sleeve 706 and the septum 708 function as a pressurerelief valve. When subjected to excess pressure in this manner, theseptum 708 moves slightly upward, which creates a gap between the bottomsurface of the septum 708 and the port opening 714. Consequently, theseptum 708 permits fluid to flow out of the fluid delivery port 704 viathe port opening 714 when the valve sleeve 706 is in the ventedposition. After the pressure is equalized, however, the valve sleeve 706and the septum 708 might naturally return to the sealed position shownin FIG. 20, especially if the fluid reservoir 700 is held in thedepicted orientation (where the force of gravity may cause the valvesleeve 706 to fall into the sealed position).

Needleless Fluid Reservoir Interface

The embodiments described above utilize a hollow needle that engages thefluid reservoir during operation of the fluid infusion device. Analternative needleless implementation will now be described withreference to FIG. 21 and FIG. 22. FIG. 21 is a longitudinalcross-sectional view of a fluid reservoir 800 and a self-sealingreservoir port receptacle 802 suitable for use with a fluid infusiondevice, and FIG. 22 is an end view of the fluid reservoir 800 as viewedfrom the perspective of line 22-22 in FIG. 21. The fluid reservoir 800and the self-sealing reservoir port receptacle 802 may be utilized withthe fluid infusion device 100 (or a slightly modified version thereof)described above with reference to FIGS. 1-6. Accordingly, commonfeatures, structures, elements, and functionality will not beredundantly described here in the context of the fluid reservoir 800 andthe self-sealing reservoir port receptacle 802.

The fluid reservoir 800 may be intended to be a user-filled orrefillable unit, or it could be designed to be a disposable pre-filledunit, depending upon the particular application. The fluid reservoir 800includes a main body section 804 that defines an interior fluid chamber806 for holding the desired fluid, e.g., a medication fluid such asinsulin. The fluid reservoir 800 also includes a fluid delivery port 808that is coupled to, and extends from, the main body section 804. Thefluid delivery port 808 includes or otherwise defines a fluid conduit810 that communicates with the fluid chamber 806. The fluid conduit 810is used to deliver the fluid from the fluid chamber 806. In certainembodiments, the fluid conduit 810 may also be used as the fill port ofthe fluid reservoir 800.

Notably, the fluid reservoir 800 is “unsealed” in that the fluiddelivery port 808 terminates at an unsealed port opening 812. In thisregard, the fluid delivery port 808 does not include a septum or anyequivalent form of fluid seal that remains in place during use of thefluid infusion device. That said, the fluid reservoir 800 could bemanufactured and provided with a protective seal or film that is removedprior to use. For instance, a prefilled version of the fluid reservoir800 may include a temporary cover, lid, or cap that can be removed priorto use. In the context of a user-filled unit, the unsealed nature of thefluid reservoir 800 allows the fluid chamber 806 to be filled in amanner that inherently equalizes the pressure. Consequently, the fluidchamber 806 will not be over-pressurized when the fluid reservoir 800 isintroduced to the fluid infusion device.

The fluid delivery port 808 and the port opening 812 are shaped andsized in accordance with the dimensions of the self-sealing reservoirport receptacle 802. More specifically, the fluid delivery port 808 andthe port opening 812 are shaped and dimensioned to facilitate mating andengagement with the self-sealing reservoir port receptacle 802. In thisregard, the fluid delivery port 808 is inserted into the self-sealingreservoir port receptacle 802 to enable the fluid reservoir 800 toprovide the medication fluid to the body of the patient via theself-sealing reservoir port receptacle 802.

In certain embodiments, the port opening 812 includes at least one flowpath 814 (see FIG. 22) that allows the medication fluid to flow from thefluid conduit 810 and into the self-sealing reservoir port receptacle802 when the fluid reservoir 800 is engaged with and coupled to theself-sealing reservoir port receptacle 802. The illustrated embodimentemploys five channels formed in the exposed rim 816 of the fluiddelivery port 808. The fluid is able to flow through these channelsduring a delivery cycle of the fluid infusion device (as described inmore detail below). In alternative embodiments, the at least one flowpath 814 may be realized as through holes, slits, or any suitablyconfigured conduit to pass the medication fluid. Moreover, the portopening 812 could be shaped (e.g., to resemble a crown) in any desiredway to enable the medication fluid to flow from the fluid conduit 810during use.

In various embodiments, the self-sealing reservoir port receptacle 802is coupled to, provided with, or incorporated into a base plate of thefluid infusion device (see, for example, a similar arrangement depictedin FIG. 1 and FIG. 3). As mentioned previously, the fluid infusiondevice may include a suitable delivery conduit, such as the cannula 112shown in FIG. 1, wherein the delivery conduit provides the medicationfluid to the body. Accordingly, the self-sealing reservoir portreceptacle 802 may be located on the base plate to establish a flow pathfor the medication fluid from the fluid reservoir 800 to the deliveryconduit.

The illustrated embodiment of the self-sealing reservoir port receptacle802 is implemented as a needleless component. In other words, a deliveryneedle is not utilized with either the self-sealing reservoir portreceptacle 802 or the fluid reservoir 800. Rather, the self-sealingreservoir port receptacle 802 incorporates a biased valve element 830that is nominally closed in its natural state, but is opened in responseto engagement of the fluid reservoir 800. Referring to FIG. 21, theexemplary embodiment of the self-sealing reservoir port receptacle 802generally includes, without limitation: an inlet 832; a valve chamber834 for the valve element 830; and an outlet 836. For this particularembodiment, the inlet 832, the valve chamber 834, and the outlet 836 arejoined together to define a continuous hollow interior pathway.

The inlet 832 is suitably configured, shaped, and sized to receive thefluid delivery port 808 of the fluid reservoir 800. For this embodiment,the inlet 832 includes an interior 838 that is sized to receive thefluid delivery port 808. In alternative embodiments, the inlet 832 maybe sized to fit inside the fluid conduit 810. The inlet 832 may alsoinclude or cooperate with a sealing element 840 that forms a seal withthe outer surface of the fluid delivery port 808 when the fluid deliveryport 808 is engaged with the inlet 832. In various embodiments, thesealing element 840 is realized as a resilient gasket, o-ring, washer,or the like. Moreover, although the depicted embodiment has the sealingelement 840 incorporated into the inlet 832, the sealing element 840 mayalternatively (or additionally) be incorporated into the fluid deliveryport 808. When the fluid delivery port 808 is engaged with the inlet832, the sealing element 840 inhibits leakage of fluid from the portopening 812 and from the valve chamber 834.

The valve chamber 834 is in fluid communication with the inlet 832. Forthis particular embodiment, the downstream end of the inlet 832corresponds to the upstream end of the valve chamber 834, as shown inFIG. 21. The valve chamber 834 is shaped, sized, and otherwiseconfigured to retain the valve element 830 while allowing the valveelement 830 to translate in the upstream and downstream directionswithin the valve chamber 834. The upstream end of the valve chamber 834may include a retaining shoulder 844 formed therein. The retainingshoulder 844 may be defined as the transition from a relatively smallinner dimension corresponding to the inlet 832 to a relatively largeinner dimension corresponding to the valve chamber 834. In other words,the retaining shoulder 844 represents a neck region that prevents thevalve element 830 from completely entering the inlet 832.

The self-sealing reservoir port receptacle 802 also includes a resilientcompression element 846 located in the valve chamber 834. The resilientcompression element 846 can be positioned between the valve element 830and the downstream end of the valve chamber 834. The resilientcompression element 846 is sized and configured to bias the valveelement 830 toward the inlet 832 (as shown in FIG. 21). In other words,the resilient compression element 846 naturally urges the valve element830 against the retaining shoulder 844 and into a sealed position toform a fluid seal between the valve element 830 and the inlet 832. Incertain embodiments, the resilient compression element 846 is realizedas a spring. Alternatively, the resilient compression element 846 couldbe realized as a compressible plug, an accordion-like member, or thelike.

The valve element 830 may be shaped and sized as appropriate for theparticular embodiment. FIG. 21 depicts one exemplary embodiment wherethe valve element 830 is realized as a ball valve, i.e., the valveelement 830 includes a spherical component. Thus, the valve chamber 834may be fabricated as a cylindrical cavity to accommodate the roundprofile of the valve element 830. Alternatively, the valve element 830could be realized as a cylindrical plug. Various shapes andconfigurations could be utilized for the valve element 830, and the ballvalve implementation is merely one suitable embodiment.

The downstream end of the valve chamber 834 is in fluid communicationwith the outlet 836 such that medication fluid can pass through thevalve chamber 834 and into the outlet 836. The outlet 836 provides afluid flow path 848 for the medication fluid. In this regard, the fluidflow path 848 may be routed through the base plate and/or through otherstructure of the fluid infusion device, and to the delivery conduit thatleads to the body of the user, as described previously. In other words,the outlet 836 can be positioned between the valve chamber 834 and thedelivery conduit.

FIG. 21 shows the self-sealing reservoir port receptacle 802 in itssealed position. The sealed state is automatically assumed in theabsence of the fluid reservoir 800. In other words, when the fluiddelivery port 808 is disengaged from the inlet 832 of the self-sealingreservoir port receptacle 802, the resilient compression element 846forces the valve element 830 toward the inlet 832 and against theretaining shoulder 844, which in turn forms a fluid seal between thevalve element 830 and the inlet 832. This seal is desirable to preventbackflow leakage of the medication fluid and to reduce the likelihood ofcontamination of the fluid path.

Engagement of the fluid delivery port 808 with the inlet 832 causes theend of the fluid delivery port 808 to contact the valve element 830.Further engagement and complete coupling of the fluid delivery port 808within the inlet 832 causes the end of the fluid delivery port 808 tomove the valve element 830 from the sealed position (shown in FIG. 21)to an opened position. In the opened position, the valve element 830 isforced in the downstream direction toward the outlet 836. As a result ofthis movement, the resilient compression element 846 becomes compressedand compacted within the valve chamber 834. Retraction of the valveelement 830 in this manner also enables the fluid delivery port 808 togain access to the valve chamber 834, which in turn accommodates flow ofthe medication fluid from the fluid reservoir 800 and into the valvechamber 834. Referring again to FIG. 22, the at least one flow path 814in the exposed rim 816 ensures that the medication fluid can flow intothe valve chamber 834 (even though the end of the fluid delivery port808 is in contact with the valve element 830).

Needled Fluid Reservoir For A Fluid Infusion Device

Most of the embodiments described previously employ a hollow fluiddelivery needle that is provided with a base plate of a fluid infusiondevice (see, for example, FIGS. 1-5). The needle in such embodimentscooperates with a sealed or an open fluid reservoir, wherein the needleis introduced into the fluid chamber of the fluid reservoir toaccommodate delivery of the medication fluid from the fluid chamber,through the needle, and to the body of the patient.

Alternatively, the embodiments presented in this section utilize aneedled fluid reservoir, i.e., a fluid reservoir having a hollow fluiddelivery needle incorporated therein. The hollow needle engages asuitably configured reservoir port receptacle, which may be located onthe base plate of the fluid infusion device. The reservoir portreceptacle includes a fluid conduit that is used to deliver themedication fluid to the body of the patient. In certain embodiments, thereservoir needle is unsealed and, therefore, open to ambient pressure.Accordingly, the fluid infusion device includes an appropriate sealingarrangement to establish a fluid seal with the hollow needle when thefluid reservoir is engaged with the reservoir port receptacle.

FIGS. 23-29 relate to a first embodiment of a needled fluid reservoir900 that is suitable for use with a compatible fluid infusion device.FIG. 23 is a perspective view of the fluid reservoir 900, and FIG. 24 isa cross-sectional view of an end portion 902 of the fluid reservoir 900.It should be appreciated that the fluid reservoir 900 could be utilizedwith a modified version of the fluid infusion device 100 described abovewith reference to FIGS. 1-6. Accordingly, common features, structures,elements, and functionality will not be redundantly described here withreference to FIGS. 23-29. Moreover, the fluid reservoir 900 shares anumber of features and elements with some of the fluid reservoirsdescribed previously. For the sake of brevity, such common features andelements will not be described in detail again in the context of thefluid reservoir 900.

Referring to FIG. 23 and FIG. 24, the fluid reservoir 900 includes amain body section 904 that defines an interior fluid chamber 906 for afluid to be delivered, such as a medication fluid. The fluid reservoir900 also includes a hollow needle 908 extending from the main bodysection 904 and defining a fluid conduit 910 (see FIG. 24) thatcommunicates with the fluid chamber 906. Although not always required,the illustrated embodiment of the hollow needle 908 is realized as aseparate component that is physically coupled to the main body section904 (and/or to a structural feature defined in the main body section904) in an appropriate manner to communicate with the fluid chamber 906.In this regard, the hollow needle 908 and the main body section 904 inthis particular embodiment are realized as two physically distinct andseparate components that are assembled together into the configurationshown in the figures. For example, the main body section 904 could befabricated from a molded plastic material, and the hollow needle 908could be fabricated from a metal material, as appropriate to thespecific embodiment. In practice, the hollow needle 908 is coupled tothe main body section 904 in a way that prevents leakage of fluidbetween the main body section 904 and the outer surface of the hollowneedle 908.

As best shown in FIG. 24, the hollow needle 908 terminates at a needleend 912 that forms or otherwise defines a blunt tip 914. The blunt tip914 may be flat (as shown), rounded, mushroom-shaped, or otherwisecontoured in a way that does not result in a sharp or pointed needle end912. Moreover, the hollow needle 908 may be unsealed such that the fluidconduit 910 remains open to ambient or atmospheric pressure, which isdesirable to enable the fluid reservoir 900 to equalize its internalpressure inside the fluid chamber 906 via the hollow needle 908. Thefluid conduit 910 is preferably sized to inhibit or prevent naturalleakage of the fluid, while still accommodating the delivery of themedication fluid from the fluid chamber 906. Moreover, for embodimentswhere the hollow needle 908 also serves as the fill needle, the fluidconduit 910 is sized to enable quick and easy filling of the fluidreservoir 900. As described in more detail below, the blunt tip 914 issuitably sized, shaped, and configured to engage a sealing element ofthe fluid infusion device.

Various embodiments of the fluid reservoir 900 include a needle hood 916that at least partially covers the hollow needle 908. The needle hood916 extends from the main body section 904 to at least partiallysurround the hollow needle 908, while still providing access to thehollow needle 908 from the end, as best shown in FIG. 23. As depicted inFIG. 24, the illustrated embodiment of the needle hood 916 is integratedwith the main body section 904. Thus, the needle hood 916 can be moldedtogether with the main body section 904 as a unitary component. Theneedle hood 916 terminates at a lip 918. In certain embodiments, the lip918 extends further from the main body section 904 than the needle end912. In other words, the blunt tip 914 of the hollow needle 908 does notprotrude from the lip 918 (see FIG. 24). This arrangement is desirableto protect the hollow needle 908 from damage and contamination. Thisarrangement also protects the user if the hollow needle 908 is providedwith a sharp tip.

The fluid reservoir 900 may also include an alignment structure thatmates with cooperating structure of the reservoir port receptacle of thefluid infusion device (see FIG. 25 and related description). Althoughnot always required, at least a portion of the alignment structure maybe integrally formed with the needle hood 916. For example, theillustrated embodiment of the fluid reservoir 900 utilizes opposingguide rails 920 and a particular shape for the needle hood 916 (e.g., aninverted “U” shape when viewed from the perspective of FIG. 23) thatcooperate to provide the desired alignment features. The guide rails 920and the shape of the needle hood 916 have corresponding mating featureson the reservoir port receptacle shown in FIG. 25.

FIG. 25 is a perspective view of a section 922 of a fluid infusiondevice, including a reservoir port receptacle 924 suitable forengagement with the fluid reservoir 900. The section 922 may represent aportion of a base plate of the fluid infusion device (see FIGS. 3-6,which show the base plate 104 with a similarly configured section forthe fluid infusion device 100). FIG. 26 is a perspective view of asealing and conduit component 926 suitable for use in the section 922shown in FIG. 25, and FIG. 27 is a cross-sectional view of the section922, as viewed from the perspective of line 27-27 in FIG. 25.

The reservoir port receptacle 924 includes suitably designed matingstructure 928 that is intended to engage and mate with the needle hood916 and, more particularly, to engage with the alignment structure ofthe needle hood 916. For this particular embodiment, the matingstructure 928 is realized as two shoulders or channels that cooperatewith the guide rails 920 when the fluid reservoir 900 is coupled to thereservoir port receptacle 924. Moreover, the overall outer shape andcontour of the reservoir port receptacle 924 can be shaped and sized tomatch the interior space defined by the needle hood 916. These featurescooperate to orient, align, and guide the needle hood 916 over thereservoir port receptacle 924. Accordingly, the alignment structure ofthe fluid reservoir 900 cooperates with the mating structure 928 toalign and orient the hollow needle 908 relative to the reservoir portreceptacle 924. This facilitates proper introduction and insertion ofthe hollow needle 908 into a sealing element 930 of the reservoir portreceptacle 924.

The sealing and conduit component 926 may be realized as an insert or aplug that is received within the section 922, as shown in FIG. 27. Thesealing element 930 may be coupled to or integrally formed with thesealing and conduit component 926, as shown in FIG. 26 and FIG. 27. Theembodiment of the sealing element 930 shown in FIG. 27 includes aself-sealing opening 932 to receive the hollow needle 908. Notably, theself-sealing opening 932 is particularly suitable for use with the blunttip 914, which is not designed to pierce or puncture the sealing element930. Rather, the blunt tip 914 can pass through the self-sealing opening932 when the fluid reservoir 900 is urged into the reservoir portreceptacle 924 (as depicted in FIG. 29).

FIG. 28 is a cross-sectional and partially phantom view that illustratesthe fluid reservoir 900 before engagement with the section 922 of thefluid infusion device, and FIG. 29 is a cross-sectional and partiallyphantom view that illustrates the fluid reservoir 900 after engagementwith the section 922. In FIG. 28, the needle end 912 has not yetcontacted the sealing element 930. Accordingly, the self-sealing opening932 exhibits a sealed or compressed state to prevent fluid ingress intoan outlet conduit 934 of the reservoir port receptacle 924. In FIG. 29,however, engagement of the fluid reservoir 900 with the reservoir portreceptacle 924 causes the blunt tip 914 to penetrate the self-sealingopening 932 such that the needle end 912 resides within the outletconduit 934. Accordingly, fluid communication is established from thefluid chamber 906 to the outlet conduit 934, via the hollow needle 908.In this state, the sealing element 930 forms a seal around the exteriorsurface of the hollow needle 908 to inhibit fluid leakage from theoutlet conduit 934.

As shown in FIGS. 27-29, the outlet conduit 934 may be at leastpartially defined by the sealing element 930. For this particularembodiment, the outlet conduit 934 is integrally formed within thesealing and conduit component 926 to provide a fluid flow path from theself-sealing opening 932, across a span of the section 922 (see FIG. 27)and into a fluid chamber 936 defined in the base plate. The fluidchamber 936 may be fluidly coupled to a delivery conduit such as acannula (see FIG. 1, which shows the cannula 112 for the fluid infusiondevice 100) for purposes of fluid delivery to the body of the patient.Thus, the sealing and conduit component 926 may be employed instead of a“J” shaped hollow needle as described above with reference to FIG. 6.

It should be appreciated that the needle hood 916 and/or the alignmentstructure of the fluid reservoir 900 may also be designed to mate andcooperate with corresponding structure of a reservoir filling apparatus.In this regard, the alignment structure could also serve to align andorient the hollow needle 908 relative to the reservoir filling apparatusto facilitate insertion of the hollow needle 908 into a sealing elementor entry port of the reservoir filling apparatus. This dual-purposenature of the needle hood 916 and alignment structure may be desirablefor embodiments of the fluid reservoir 900 that use the same hollowneedle 908 for both filling and delivery of the medication fluid.

FIGS. 30-33 relate to a second embodiment of a needled fluid reservoir940 that is suitable for use with a compatible fluid infusion device.The fluid reservoir 940 and the related features of the fluid infusiondevice are similar in many respects to that described above for thefluid reservoir 900. Accordingly, for the sake of brevity and clarity,the following description referring to FIGS. 30-33 is abbreviated innature.

The fluid reservoir 940 is very similar to the fluid reservoir 900,except for its use of a hollow needle 942 terminating at a sharp tip 944(rather than a blunt or rounded tip). Likewise, the sealing and conduitcomponent 946 shown in FIG. 31 is substantially identical to the sealingand conduit component 926 described above. Notably, however, the sealingand conduit component 946 includes a pierceable sealing element 948(rather than a self-sealing element having a predefined slit, hole, orslot formed therein) that is suitably configured to accommodate thesharp tip 944. Thus, the sharp tip 944 pierces the sealing element 948when the fluid reservoir 940 is coupled to the reservoir port receptacle950.

FIG. 32 is a cross-sectional and partially phantom view that illustratesthe fluid reservoir 940 before engagement with the reservoir portreceptacle 950, and FIG. 33 is a cross-sectional and partially phantomview that illustrates the fluid reservoir 940 after engagement with thereservoir port receptacle 950. In FIG. 32, the hollow needle 942 has notyet contacted the sealing element 948, which remains solid and intact.In FIG. 33, however, engagement of the fluid reservoir 940 with thereservoir port receptacle 950 causes the sharp tip 944 to pierce thesealing element 948 such that the end of the hollow needle 942 resideswithin the outlet conduit 952. Accordingly, fluid communication isestablished from the fluid chamber 954 of the fluid reservoir 940 to theoutlet conduit 952, via the hollow needle 942. In the state depicted inFIG. 33, the sealing element 948 forms a seal around the exteriorsurface of the hollow needle 942 to inhibit fluid leakage from theoutlet conduit 952.

FIGS. 34-39 relate to a third embodiment of a needled fluid reservoir960 that is suitable for use with a compatible fluid infusion device.The fluid reservoir 960 and the related features of the fluid infusiondevice are similar in many respects to that described above for thefluid reservoir 900. Accordingly, for the sake of brevity and clarity,the following description referring to FIGS. 34-39 is abbreviated innature.

The fluid reservoir 960 is very similar to the fluid reservoir 900,except for its use of an integrated hollow needle 962 rather than aphysically distinct and separate needle component. In this regard, thehollow needle 962 is integrated and contiguous with the main bodysection 964 of the fluid reservoir 960. In certain embodiments, thehollow needle 962 and the main body section 964 are molded together fromthe same material (e.g., a plastic material) to create a unitary singlecomponent. The integrated nature of the hollow needle 962 is depicted inFIG. 35, which shows how the base 966 of the hollow needle 962 blendswith (and is continuous with) the main body section 964. Although notalways required, the illustrated embodiment of the hollow needle 962terminates at a rounded, blunt tip 968. Alternatively, a pointed,angled, or sharp tip could be utilized.

FIG. 36 depicts a section 970 of the fluid infusion device; the section970 may represent a portion of the base plate (as described above). Thesection 970 houses a sealing and conduit component 972, which has thegeneral characteristics and functionality described above for theprevious two embodiments. The sealing and conduit component 972 includesor cooperates with a sealing element 974, which is accessible via areservoir port receptacle 976. Notably, the sealing element 974 has anunsealed (open) inlet end 978 that is sized, shaped, and otherwiseconfigured to receive the hollow needle 962. Moreover, the illustratedembodiment of the sealing element 974 has an outlet end 980 that isdownstream from the inlet end 978. The outlet end 980 includes,cooperates with, or defines a pressure valve 982 that actuates inresponse to a fluid delivery action of the fluid infusion device, toaccommodate flow of the medication fluid from the hollow needle to anoutlet conduit 984. Consequently, even though the inlet end 978 of thesealing element 974 is open and exposed, the outlet conduit 984 isprotected by the pressure valve 982 when the fluid reservoir 960 isremoved from the reservoir port receptacle 976.

FIG. 38 is a cross-sectional and partially phantom view that illustratesthe fluid reservoir 960 before engagement with the reservoir portreceptacle 976, and FIG. 39 is a cross-sectional and partially phantomview that illustrates the fluid reservoir 960 after engagement with thereservoir port receptacle 976. In FIG. 38, the hollow needle 962 has notyet entered the sealing element 974. In FIG. 39, however, engagement ofthe fluid reservoir 960 with the reservoir port receptacle 976 urges thehollow needle 962 into the inlet end 978 of the sealing element 974 suchthat the end of the hollow needle 962 resides within a valve chamber 986defined within the sealing element 974. Accordingly, fluid communicationis established from the fluid chamber 988 of the fluid reservoir 960 tothe valve chamber 986, via the hollow needle 962. In the state depictedin FIG. 39, the sealing element 974 forms a seal around the exteriorsurface of the hollow needle 962 to inhibit fluid leakage from the valvechamber 986.

FIG. 39 depicts the pressure valve 982 in a closed state, which isindicative of a lack of sufficient fluid pressure within the valvechamber 986. In contrast, when the plunger (not shown) of the fluidreservoir 960 is activated for a fluid delivery pulse, cycle, or action,the pressure valve 982 actuates and opens to accommodate flow of themedication fluid from the hollow needle 962 and through the pressurevalve 982, by way of the valve chamber 986. The medication fluid is alsourged through the outlet conduit 984, which may lead to a cannula thatprovides the medication fluid to the body of the patient.

While at least one exemplary embodiment has been presented in theforegoing detailed description, it should be appreciated that a vastnumber of variations exist. It should also be appreciated that theexemplary embodiment or embodiments described herein are not intended tolimit the scope, applicability, or configuration of the claimed subjectmatter in any way. Rather, the foregoing detailed description willprovide those skilled in the art with a convenient road map forimplementing the described embodiment or embodiments. It should beunderstood that various changes can be made in the function andarrangement of elements without departing from the scope defined by theclaims, which includes known equivalents and foreseeable equivalents atthe time of filing this patent application.

What is claimed is:
 1. A fluid infusion device that delivers amedication fluid to a body, the fluid infusion device comprising: afluid reservoir comprising a main body section that defines a fluidchamber for the medication fluid, and comprising a fluid delivery portcoupled to and extending from the main body section, the fluid deliveryport comprising a fluid conduit that communicates with the fluidchamber, and the fluid delivery port terminating at an unsealed portopening; and a self-sealing reservoir port receptacle for the fluiddelivery port, comprising an inlet to receive the fluid delivery port, avalve chamber in fluid communication with the inlet, a valve elementlocated in the valve chamber, and an outlet in fluid communication withthe valve chamber; wherein: the valve element is biased toward the inletinto a sealed position to form a fluid seal between the valve elementand the inlet; the outlet provides a fluid flow path for the medicationfluid; engagement of the fluid delivery port with the inlet causes anend of the fluid delivery port to move the valve element from the sealedposition to an opened position to accommodate flow of the medicationfluid into the valve chamber; the port opening comprises at least oneflow path that allows the medication fluid to flow from the fluidconduit and into the valve chamber when the valve element is in theopened position; and the at least one flow path comprises a plurality ofchannels defined in a rim of the fluid delivery port, and the pluralityof channels are spaced apart along a perimeter of the rim.
 2. The fluidinfusion device of claim 1, further comprising a resilient compressionelement located in the valve chamber to bias the valve element towardthe inlet.
 3. The fluid infusion device of claim 2, wherein theresilient compression element comprises a spring.
 4. The fluid infusiondevice of claim 1, wherein the valve element comprises a ball valve. 5.The fluid infusion device of claim 4, wherein the valve chamber includesat least one retaining shoulder to permit a portion of the ball valve toenter the inlet.
 6. The fluid infusion device of claim 1, furthercomprising a sealing element to form a seal between the fluid deliveryport and the inlet when the fluid delivery port is engaged with theinlet.
 7. The fluid infusion device of claim 6, wherein the sealingelement is incorporated into the inlet.
 8. The fluid infusion device ofclaim 6, wherein the sealing element is incorporated into the fluiddelivery port.
 9. A fluid infusion device that delivers a medicationfluid to a body, the fluid infusion device comprising: a fluid reservoircomprising a main body section that defines a fluid chamber for themedication fluid, and comprising a fluid delivery port coupled to andextending from the main body section, the fluid delivery port comprisinga fluid conduit that communicates with the fluid chamber, and the fluiddelivery port terminating at an unsealed port opening; a self-sealingreservoir port receptacle for the fluid delivery port, comprising aninlet to receive the fluid delivery port, a valve chamber in fluidcommunication with the inlet, a valve element located in the valvechamber, the valve element biased toward the inlet to form a fluid sealbetween the valve element and the inlet, and an outlet in fluidcommunication with the valve chamber to provide a fluid flow path forthe medication fluid; and a sealing element disposed in the inlet toform a seal with an outer surface of the fluid delivery port, thesealing element positioned between the inlet and the valve chamber;wherein engagement of the fluid delivery port with the inlet moves thevalve element from a sealed position at the inlet into an openedposition to accommodate flow of the medication fluid into the valvechamber.
 10. The fluid infusion device of claim 9, further comprising aresilient compression element located in the valve chamber to bias thevalve element into the sealed position.
 11. The fluid infusion device ofclaim 9, wherein the valve element comprises a ball valve.
 12. The fluidinfusion device of claim 11, wherein the valve chamber includes at leastone retaining shoulder at an upstream end to permit a portion of theball valve to enter the inlet.
 13. The fluid infusion device of claim 9,wherein the port opening comprises at least one flow path that allowsthe medication fluid to flow from the fluid conduit and into the valvechamber when the valve element is in the opened position.
 14. The fluidinfusion device of claim 13, wherein the at least one flow pathcomprises a plurality of channels defined in a rim of the fluid deliveryport, and the plurality of channels are spaced apart along a perimeterof the rim.
 15. The fluid infusion device of claim 9, wherein themedication fluid comprises insulin.
 16. The fluid infusion device ofclaim 9, wherein an end of the fluid delivery port moves the valveelement into the opened position.
 17. A fluid infusion device thatdelivers a medication fluid to a body, the fluid infusion devicecomprising: a fluid reservoir comprising a main body section thatdefines a fluid chamber for the medication fluid, and comprising a fluiddelivery port coupled to and extending from the main body section, thefluid delivery port comprising a fluid conduit that communicates withthe fluid chamber, and the fluid delivery port terminating at anunsealed port opening, the port opening including a plurality of flowpaths that allow the medication fluid to flow from the fluid conduit; aself-sealing reservoir port receptacle for the fluid delivery port,comprising an inlet to receive the fluid delivery port, a valve chamberin fluid communication with the inlet, a valve element located in thevalve chamber, the valve element biased toward the inlet to form a fluidseal between the valve element and the inlet, and an outlet in fluidcommunication with the valve chamber to provide a fluid flow path forthe medication fluid; and a sealing element disposed in the inlet toform a seal with an outer surface of the fluid delivery port; whereinengagement of the fluid delivery port with the inlet moves the valveelement from a sealed position at the inlet to an opened position toaccommodate flow of the medication fluid into the valve chamber, and themedication fluid flows from the fluid conduit through the plurality offlow paths and into the valve chamber.